Orthopedic casting articles

ABSTRACT

An orthopedic casting article comprising a polymeric foam tape containing one or more curable resins. The polymeric foam tape can be a foam having a substantially open cell structure, substantially closed cell structure, or a substantially reticulated cell structure. The curable resin can be a water-curable resin. The casting article can be multi-layered to obtain an article suitable for splinting applications.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. provisionalapplication Serial No. 60/469,609, filed on May 9, 2003.

BACKGROUND OF THE INVENTION

[0002] There are various types of immobilization tapes and splintsavailable on the market and described in literature. Plaster of Pariscasting tapes, used since the 19^(th) century, Fiasco and Stills,JOURNAL OF PROSTHETICS AND ORTHOTICS, 1991, 3(2), 55-58, are basicallygauzes impregnated with gypsum. They are activated by immersion in waterfor a few seconds and then applied around joints or fractures beforethey set hard. The set time for Plaster of Paris tapes can be longbefore their maximum strength is achieved. The main disadvantages ofPlaster of Paris immobilization tapes are their poor strength to weightratios, which results in finished casts and splints that are often bulkyand heavy, and poor resistance to water, which makes showering andbathing difficult.

[0003] More recently, synthetic casting and immobilization tapes andsplits were developed, which consist of substrates and water curablepolymeric resins. The polymeric resins can be water cured or waterreactive NCO-polyurethane prepolymers, as disclosed in U.S. Pat. Nos.4,131,114; 4,376,438; 4,433,680; 4,502,479; 4,655.208; 4,667,661; and5,244,997. The water cured polymeric resins can be coated ontosubstrates which are most commonly fiberglass or polyester, as disclosedin U.S. Pat. Nos. 3,972,323; 4,502,479; 4,688,563; 4,609,578; 4,841,958;and 5,014,403. There are numerous polyisocyanate immobilization tapesavailable on the market. The set time of synthetic tapes is, in general,shorter than that for Plaster of Paris tapes. The synthetic casts havegood resistance to water and higher strength-to-weight ratio thanPlaster of Paris tapes.

[0004] Woven or knitted fiberglass fabrics are frequently utilized assubstrates to carry the water curable resins, as disclosed in U.S. Pat.Nos. 4,502,479; 4,668,563; 4,609,578; and 5,014,403. The fiberglassfabric is commonly cut before application, which can results in fiberssticking out. After the water curable prepolymer resin cures and tapesharden, the fibers can protrude from the edges and can becomeneedle-like and can penetrate the protective fabric and contact the skinresulting in cuts and skin irritation. Similar problems can occur withsubstrates fabricated from other woven or knitted fibers. In addition,during the cutting of cured tapes, the fiberglass particles can becomeair-born, which can be hazardous if inhaled. In addition, water curablepolymeric resins may have insufficient adhesion to the fiberglass.

[0005] Woven or knitted polyester fibers are also widely used assubstrates that carry water curable polymeric resins. Polyester tapesare softer and have better elasticity than fiberglass tapes. However,polyester substrates can be susceptible to moisture, which can affectthe stability of the water curable polymeric resins and thereforeshelf-stability of the tapes or splints.

[0006] Other types of immobilization tapes have been developed thatutilize woven and non-woven substrates that include natural organicfabrics (e.g. cotton and wool), natural organic polymers fibers (e.g.acetate, rayon), synthetic organic polymers fibers (nylon), etc. Thenon-woven substrates tend to have smoother edges than woven substrates,however, they tend to be thicker, which makes it more difficult toevenly spread the water curable resins, and can lessen the moldabilityof tapes and splints as disclosed in U.S. Pat. Nos. 4,351,683;4,683,877; 4,888,225; and 4,946,726.

[0007] U.S. Pat. Nos. 4,888,225 and 4,946,726 disclose orthopedicsplinting articles for use with animal body parts, which comprise of acellular material unitary blank with water curable isocyanate functionalpolyurethane prepolymer resin. The blank is dimensioned to extend thelength of the body part to be immobilized and to partially, but notcompletely, extend around the circumference of the body part. Thesesplinting articles are limited to pre-fabricated designs, manufacturedfrom one piece and one layer of cellular material unitary blank which isone-quarter inch to one-half inch thick. It is extremely difficult toevenly load viscous curable isocyanate resins throughout such thickcellular foams blank, which can lead to suboptimal properties of curedorthopedic splinting articles.

[0008] As an alternative, U.S. Pat. Nos. 4,888,225 and 4,946,726 proposethat a water-curable resin can be prepared by reacting polyol andpolyisocyanate reagents in-situ in the foam substrate, which can be verydifficult to control as the reagents would not necessarily get adequatemixing, which could lead to incomplete reaction and in turn to poorquality water-curable resin in the foam substrate. Furthermore, sidereactions with foam substrate can occur which can further change theproperties of the curable resin and the foam substrate. As a result,these splinting articles based on a one layer, unitary blank have foundlimited, if any, application in the orthopedic splinting applications.

[0009] U.S. Pat. No. 3,728,206 discloses a composite orthopedicsupportive structure comprised of a non-woven open cell foam that isimpregnated with crystalline thermoplastic material such aspolyisoprene. This orthopedic supportive structure is heated to anelevated temperature until the crystalline thermoplastic material meltsand it is applied to the body part while hot. The composite subsequentlycrystallizes and hardens when cooled down to room temperature.Additionally, the cooling of the crystalline thermoplastic material cantake a relatively long time, which is undesirable in immobilizationapplications. Furthermore, application to the body member while hotmakes the utilization of such orthopedic supportive structures extremelyundesirable as it may result in burns. Therefore, these orthopedicsupportive structures have found no significant, if any, application inthe orthopedic immobilization applications.

[0010] In light of the foregoing, there is a need for the orthopedicimmobilization tapes which are not woven and not knitted, that can besoft and flexible, can have good moldability, can have good adhesion tocurable resin and that can facilitate easy loading of the resin into thesubstrate, and the orthopedic immobilization tapes thin enough that canbe used as orthopedic winding casting tapes or layered for use inorthopedic casting splinting articles, that when cured can hardenadequately to provide required immobilization.

SUMMARY OF THE INVENTION

[0011] According to one embodiment of the present invention, anorthopedic casting article including a polymeric foam tape containingone or more curable resins is disclosed. The one or more curable resinscan applied on one side or both sides of the polymeric foam tape. Incertain applications, the polymeric foam tape can have a thickness ofabout {fraction (1/128)} inch (about 0.2 mm) to about {fraction (3/16)}inch (about 5 mm), a width of about ½ inch to about 24 inches, and alength of at least about 6 inches. The polymeric foam can bethermosetting or thermoplastic, and can have a uniform or variablepolymer composition structure. The polymeric foam can be flexible,semi-rigid, semi-flexible, viscoelastic, resilient or rigid. Thepolymeric foam can have a substantially open cell structure, asubstantially closed cell structure, or a substantially reticulated cellstructure. In certain applications, the polymeric foam can have anaverage cell density greater than about 10 pores per inch (ppi) and anelasticity greater than about 1%. The polymeric foam can be a foamhaving an affinity to water in the range of hydrophilic to hydrophobic.The average density of the polymeric foam used in certain applicationsof the present invention can be about 1.6 kg/m³ to about 960 kg/m³.

[0012] The polymeric foam tape can include a foam having at least onevariable property throughout, wherein the variable property is selectedfrom the group consisting of density, cell density, cell geometry, cellsize, affinity to water, elasticity, thickness and width. The polymericfoam tape can include a foam based on one or more isocyanate orisocyanate containing compounds. The one or more isocyanates andisocyanate containing compounds can include aliphatic isocyanate,aromatic isocyanate, cycloaliphatic isocyanate or a mixture thereof. Incertain applications, the polymeric foam tape includes a polyurethanefoam, being a product of a reaction of one or more polyols with one ormore isocyanates or isocyanate containing compounds. In otherapplications, the polymeric foam tape includes a polyurea foam, being aproduct of a reaction of one or more polyamines with one or moreisocyanates or isocyanate containing compounds. As non-limitingexamples, The polymeric foam tape can be selected from the groupconsisting of polyolefin-based polymers, polyester-based polymers,polyether-based polymers, polystyrene-based polymers, and mixturesthereof.

[0013] The polymeric foam tape can include one or more additives toalter the surface properties of the polymeric foam or adhesion to theone or more curable resins. The curable resin can be applied to thepolymeric foam tape at a load of about 99/1 resin to polymeric foam tapeweight ratio to 1/99 resin to polymeric foam tape weight ratio. Incertain applications, at least one of the one or more curable resins canbe a water-curable resin. In other applications, at least one of the oneor more water curable resins can be an isocyanate containing material.The isocyanate containing material can be selected from the followinggroup: aromatic isocyanates, aliphatic isocyanates, cycloaliphaticisocyanates, isocyanate-based adducts, isocyanate-based derivatives,isocyanate-prepolymers, isocyanate-oligomers and isocyanate-quasiprepolymers. In certain applications, the isocyanate containing materialhas an isocyanate to active hydrogen equivalent weight ratio greaterthan about 1. The isocyanate containing material can contain at leastone catalyst promoting the reaction of the isocyanate with water. Incertain applications, at least one of the one or more water curableresins can be Plaster of Paris. At least one of the one or more curableresins can be cured via chemical reaction, UV light, laser light,radiation, or heat induced reaction.

[0014] According to another embodiment of the present invention, anorthopedic casting splint including two or more layers is disclosed. Oneor more of the layers includes a polymeric foam tape containing one ormore curable resins. The polymeric foam tape can include a thermoset orthermoplastic polymeric foam. The polymeric foam tape can include a foamhaving a substantially open cell structure, a substantially closed cellstructure, or a substantially reticulated cell structure. One or morelayers of the splint can include a woven, non-woven, knitted, orextruded layer. In certain applications, the splint can be made in theshape of a sleeve or glove.

[0015] In yet another embodiment, a method for applying an orthopediccasting article to a body member is disclosed. The method includeswinding a polymeric foam tape containing one or more curable resinsaround a body member; and curing the one or more curable resins before,during, or after the polymeric foam tape is wound around the bodymember. In certain applications, the method can further include cuttingor slicing the polymeric foam tape to a length capable of partially orfully immobilizing the body member.

[0016] In another embodiment of the present invention, a method forapplying an orthopedic casting splint to a body member is disclosed. Themethod includes providing a splint comprising two or more layers of apolymeric foam tape, wherein at least one of the layers contains one ormore curable resins; fully or partially enveloping the splint around abody member; and curing the one or more curable resins before, during,or after the polymeric foam tape is enveloped around the body member. Incertain applications, the method can further include cutting or slicingthe splint to a shape capable of partially or fully immobilizing thebody member. The enveloping step can include inserting the body memberinto the splint.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The features of the present invention which are believed to benovel are set forth with particularity in the appended claims. Thepresent invention, both as to its organization and manner of operation,together with further objects and advantages thereof, may best beunderstood with reference to the following description, taken inconnection with the accompanying drawings which:

[0018]FIGS. 1a and 1 b depict schematics of cell structural elements infoams with open and closed cells, respectively;

[0019]FIG. 2 depicts a microscopic image of foam with open cellstructure;

[0020]FIG. 3 depicts a microscopic image of a foam with a mixture ofclosed and open cells;

[0021]FIG. 4 depicts a microscopic image of a foam with an openreticulated cell structure;

[0022]FIG. 5a depicts a role of continuous single-layered foam tapecontaining a curable resin in accordance with one embodiment of thepresent invention;

[0023]FIG. 5b depicts the role of FIG. 5a which has been cut into adesired length;

[0024]FIG. 5c depicts the desired length of 5 b which has been woundaround a body member;

[0025]FIG. 6a depicts a role of continuous multi-layered foam tape inwhich at least one layer of foam tape containing a curable resin inaccordance with one embodiment of the present invention;

[0026]FIG. 6b depicts the role of FIG. 6a which has been cut into adesired length;

[0027]FIG. 6c depicts the desired length of FIG. 6b which has beenenveloped around a body member as a splint to partially or completelyimmobilize a circumference of the body member; and

[0028]FIG. 7 depicts a multi-layered foam sleeve tube which contains acurable resin that is pulled onto a body member as to partially orcompletely immobilize a circumference of the body member.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

[0029] As required, detailed embodiments of the present invention aredisclosed herein. However, it is to be understood that the disclosedembodiments are merely exemplary of an invention that may be embodied invarious and alternative forms. Therefore, specific functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for the claims and/or as a representative basis forteaching one skilled in the art to variously employ the presentinvention.

[0030] One aspect of the present invention provides orthopedicimmobilization tapes and casting articles that for at least one of itscomponents contain a polymeric foam tape substrate onto which a curableresin is applied. A variety of polymeric foams can be used in thepresent invention that includes polyurethane foams. Other non-limitingexamples of polymeric foams that can be used in accordance with thepresent invention include polyurea foams, polyolefin foams, polyesterfoams, polystyrene foams, and polyether foams. A variety of curableresins can be used that include water-curable resins, and water-curablepolyurethane resins.

[0031] One aspect of the present invention provides orthopedicimmobilization tapes and casting articles that for at least one of itscomponents contain a polymeric foam tape substrate onto which a curableresin is applied.

[0032] A variety of polymeric foams can be used in the present inventionthat includes polyurethane foams. The cell structure of the polymericfoams can be closed or open, preferably mostly open, and most preferablyfully open and/or reticulated open cell structure. Depending on theapplication needs of the immobilization tape or casting article, thepolymeric foams can be rigid, semi-flexible, or flexible. The foams canhave elasticity greater than about 1%. A variety of additives can beadded to the foam to affect their physical properties, mechanicalproperties, surface properties, color, tackiness, adhesion to resins,etc.

[0033] A variety of curable resins can be used that, as non-limitingexamples, include water-curable resins and water-curable polyurethaneresins. A variety of additives can be added to the curable resins toaffect their adhesion to the foam, color, tackiness of the tape, curedphysical and mechanical properties of the tape, surface properties ofthe tape before and/or after curing, etc.

[0034] Curable resins can be coated or applied onto polymer foam tapesubstrates according to any techniques utilized in coating orapplication of curable resins onto substrates (woven, non-woven,knitted, extruded, etc.) including, but not limited to, roller coating,spray coating, transfer coating, immersion coating, or any other methodknown to those in the art of coatings and coating application.

[0035] The orthopedic immobilization tapes and casting articles of thepresent invention are packaged in a way to minimize exposure to waterthat includes, but is not limited to, dry packaging, vacuum packaging,etc.

[0036] The orthopedic immobilization tapes and casting articles, thatinclude splints, are used in a manner which is typical for syntheticorthopedic tapes and casting articles.

[0037] Synthetic orthopedic tapes and casting articles, includingsplints, are disclosed that for at least one of its components contain apolymeric foam tape substrate onto which a curable resin is applied.Various types of polymeric foam materials can be utilized in the presentinvention that include polyurethane foams, and foams with a variety ofcell structures, in particular foams with mostly open, and fully opencell structures that include reticulated foams. In certain embodiments,thin substantially open cell and reticulated foams with thicknessdimensions of less than about {fraction (3/16)} inch allow for asubstantially even distribution of the resin through the foam thickness,resulting in cured tapes with good immobilization properties.Furthermore, for thin tapes with thickness dimension of less than about2 mm, in addition to substantially open cell foams, partially closed orsubstantially closed cell foams can satisfactorily absorb the curableresin. Various types of curable resins can be applied on the polymericfoam tape substrates. In some embodiments, these resins are watercurable resins, and in other embodiments they are water curablepolyurethane-based resins.

[0038] One aspect of this invention relates to orthopedic immobilizationtapes and casting articles, including splints, having at least one layerof foam tape which contains one or more curable resins. In particular,at least one of the substrates, onto which curable resins are applied,is made of polymeric cellular tape materials or polymeric foam tape.

[0039] The polymeric foams (or polymeric cellular materials) can beprepared virtually from any polymer by the introduction of gas intopolymer matrix, as is known to those familiar in the art of polymericfoam synthesis and preparation. Polymeric foams used in the presentinvention can have density from about 1.6 kg/m³ to about 960 kg/m³(about 0.1 pcf to about 60 pcf) and can have uniform or variable densitythroughout its thickness.

[0040] The foaming of polymeric foams can be carried out by chemical,physical or mechanical means (Handbook of Polymeric Foams and FoamTechnology, Hanser Publishers. 1991/edited by D. Klempner & K. C.Frisch). A non-limiting examples of foaming techniques includes:

[0041] a. Volatilization of low-boiling liquids (such as fluorocarbonsor methylene chloride) within the polymer mass as a result of theexothermic heat of reaction or by application of heat.

[0042] b. Volatilization of gasses produced during polymerization, suchas in the reaction of isocyanate and water in the polyurethane foamformation.

[0043] c. Thermal decomposition of chemical blowing agents, whichgenerate gases through application of heat or exothermic heat ofpolymerization reaction.

[0044] d. Mechanical whipping of gases (frothing) into polymer system(melt, solution or suspension), which hardens either by catalytic actionand/or heat, entrapping the gas bubbles in the matrix.

[0045] e. Expansion of gas dissolved in a polymer mass upon reduction ofthe pressure in the system.

[0046] f. Incorporation of hollow microspheres into polymer mass.

[0047] g. In addition to the above listed techniques, foams can be usedin the tape substrates of the presented invention prepared according toany method known to those skilled in the art of polymeric foam synthesisand preparation.

[0048] The polymeric foams can be thermoplastic or thermosetting. Thepolymeric foams can be made of a variety of chemical compositions andchemical blends. In addition, blends and composites of two or morepolymeric foams can be used as the foam tape substrates of the presentinvention, that can have same or different chemical compositions,molecular weights, cell size and morphology (geometry, weightdistribution between windows and struts), and bulk densities. The foamtape substrates can, but do not necessarily have to, contain one or moreorganic and/or inorganic fillers and additives, which as non-limitingexamples can include glass beads, ceramics, organic fibers, carbonblack, dyes, lubricants, tack control agents, fiberglass, etc.Composites of polymeric foams with fiberglass, polyester, natural fiber,synthetic fibers, and non-cellular polymeric materials and substratescan be utilized in the orthopedic tapes (see FIGS. 5a, 5 b, and 5 c) andcasting articles (including splints) of this invention as well.According to FIGS. 6a, 6 b, and 6 c, a casting splint can bemulti-layered with at least one layer comprised of a foam tape substratethat contains a curable resin.

[0049] The polymeric foams used in the present invention can have cellswith a variety of cell shapes, cell sizes, and morphologies. The foamscan have uniform or varying cell size, cell shapes, and cell densitythroughout its thickness. In the polymeric foam tape substrates used inthe present invention, the foam cell structure may be open (tunnelsbetween cells) or closed cells (windows separating cells), or anymixture of open/closed cells, or reticulated open cell structure. Incertain embodiments, the substrates are made of polymeric tape foam thathave mostly open cells structure, fully open cells structure, and morespecifically in certain embodiments an open reticulated structure. Foamswith closed or mostly closed cell structure can be used if adequatenumber of cells are opened during any point of the fabrication process(non limiting example is crushing). The cell density in the polymericfoam substrates can vary from about 3 cells (pores) per inch (ppi) toabout 1000 ppi.

[0050] Reticulated foams are a special type of open cell structure foamsin which the cells do not have windows, but only the cell struts.(HANDBOOK OF POLYMERIC FOAMS AND FOAM TECHNOLOGY, Hanser Publishers1991/edited by D. Klempner & K. C. Frisch.) Reticulated foams aretypically prepared by removal of the cell windows in the post-treatmentprocedure of the already made foam, either by melting (thermalprocedure) or by dissolving (solvents, alkaline solutions). Reticulatedfoams prepared by any method or procedure can be used as the foam tapesubstrates in the present invention. As a non-limiting example, an imageof a polyurethane reticulated foam is shown in FIG. 4. Generalinformation on commercial reticulated polyurethane foam products, as nonlimiting examples, can be found in the Technical Product Function Sheet,Foamex Co., 1500 East Second Street, Eddistone, Pa. 19022.

[0051] Polymeric foam tape substrates used in the present invention canbe produced of various shapes, lengths, thicknesses, or widths. Thesetape substrates can be made by a variety of methods that are known tothose familiar with the art of polymer manufacturing. As a non-limitingexample, a continuous sheet of polymeric foam tape substrate (see FIGS.5a, 5 b, and 5 c and FIGS. 6a, 6 b, and 6 c) can be sliced or cut from acylindrical shaped polymeric foam bun. After slicing or cutting thepolymeric foam tape substrate can be, but does not necessarily have tobe, thermoformed entirely or partially to reinforce the tapes, changedensity, alter porosity, or introduce a variety of patterns, includingalternating thick and thin parts. If needed the foams can be also sewn,stapled, and/or glued. A stretchable sleeve can be cut from acylindrical shaped polymeric foam bun onto which a water curable resinis applied, and that could be used as a splint or immobilizationorthopedic tape. A stretchable sleeve can be made by a variety ofmethods that, as non-limiting examples, include gluing, stapling,sewing, melting, and/or pressing together opposite edges of a sheet.

[0052] Polymeric foams used in the present invention can have a range offlexibilities that include flexible, semi-rigid, and rigid foams. Insome embodiments, semi-rigid foam is used, and in other embodiments,flexible foams are used.

[0053] In one embodiment, it is preferred, that polymeric foams,including polyurethane foams, are viscoelastic (energy absorbing) andflexible foams that have good moldability that allows the casting tapesand casting article to effectively align to the morphology of the body.

[0054] In another embodiment, high resilient polymeric foam tapesubstrates can be used in the casting tapes and casting articles of thepresent invention.

[0055] The elasticity of the foam tape substrates can be about 1% orhigher. As non-limiting examples, the elasticity of foams can becontrolled by the chemical composition of the foams, cell structures,bulk density of the foams, or by the addition of various additives.

[0056] The foams, including polyurethane, may be colored by adding dyesor pigment to the foams, during the foam preparation or in thepost-treatment procedure. A variety of motifs can be printed on thepolymeric foam tape substrates. Curing agents that are applied on thefoam tape substrate can be dyed as well.

[0057] As non-limiting examples, the physical properties of the castingtapes and casting articles can be optimized for specific orthopedicapplication by altering the foam tape substrates properties, forexample, chemical composition, density, elasticity, cell size andgeometry, through addition of additives, preparation of blends,composites, etc. In addition, the tape casting and/or casting articleproperties can be optimized by altering the curing agents properties,such as, formulation, chemical composition, through addition ofadditives, lubricants, etc.

[0058] In some embodiments it might be preferred, that the polymericfoam tape substrates are hydrophobic, and in other embodiments it mightbe preferred that they are hydrophilic.

[0059] The polymeric foam tape substrate can be coated with variousadditives, polymers, or even foamed product to impart differentproperties, such as, various degrees of surface energy,hydrophobicity/hydrophilicity, rigidity, adhesion, etc.

[0060] Polymeric foam tape substrates used in the orthopedic tapes andcasting articles of the present invention can be polyurethane foams.However, other types of cellular polymeric materials can be utilized astape substrates (ex. polyolefin, polyester, etc.). The followingexamples are non-limiting. Polyurethane foams are in general prepared bythe reaction of polyol and/or polyamine functionalized reactants withisocyanate-functionalized reactants. As non-limiting examples, polyolsand/or polyamines can have the following chemical compositions:aliphatic, cycloaliphatic, aromatic, polyether, polyester,polycarbonate, hydrocarbone, silicone, acrylic, grafted polymers, or anycombination thereof. As non-limiting examples, isocyanates can bearomatic, aliphatic and cycloaliphatic or their mixtures. Othernon-limiting examples of suitable isocyanates include 2,4-toluenediisocyanate, 2,6-toluene diisocyanate, 2,4′-diphenylmethanediisocyanate, 4,4′-diphenylmethane diisocyanate,4,4′-dicyclohexylmethane diisocyanate, etc. Mixtures of any isocyanatescould be utilized as well. As non-limiting examples, water or lowboiling solvents (e.g. pentane) can be used as a blowing agent in thepreparation of the polymeric foams. Polyurethane foams can be made alsoby reacting blocked isocyanate and polyols or polyamines. In thisreaction, a low boiling blocking agent is released and acts as a blowingagent. Polyurethane foams can also be made by introducing liquid orsolid blowing agent to polyurethane thermoplastic resin. Polyurethanefoams can be made with or without cell forming surfactants. In certainembodiments, polyurethane foams can be made with the presence of a cellforming surfactant. Various types of catalyst can, but do notnecessarily have to be used in the polyurethane foam preparation.Examples of catalysts include urethane foaming catalyst dibutyltindilaurate, blowing/gelling amine catalysts diazobicyclo octane, etc.

[0061] Polymeric foam tape substrates used in the present invention canbe biodegradable. Polymeric foam tape substrates used in the presentinvention can contain flame retarding agents to make them non-flammableand/or self-extinguishing.

[0062] Synthetic casting tapes and casting articles can be prepared bycoating or applying curable resins, and in some embodiments watercurable resins, onto at least one polymeric foam tape substrate. It ispreferred, but not necessary, to use water curable polyurethane(NCO-functional) prepolymer resins. Curable resins can be coated orapplied onto polymer foam substrates according to any techniquesutilized in coating of reactive (curable) resins on substrates (woven,knitted, non-woven, extruded, etc.), including, but not limited to,roller coating, spray coating, transfer coating, immersion coating, orany other method known to those in the art of coatings and coatingsapplications.

[0063] The application of the presented immobilization tapes and castingarticles is in accordance to the methods in which synthetic castingtapes and other casting articles, that includes splints, are utilized.

[0064] The curable resin can be tacky or non-tacky, may contain somefillers, catalysts, isocyanate stabilizers, anti-foaming agents, etc. Asa non-limiting example, it is noted that good absorption of theisocyanate reactive resin by the polyurethane foam tape substrate mayreduce tackiness of the synthetic tapes that is often observed whenother substrates are utilized. The composition and amount of resinapplied onto the foam tape substrate can vary, and can be adjusteddepending on the immobilization applications needs.

[0065] Polymeric foam tape substrates may, but do not necessarily haveto, contain various fillers such as, but not limited to, barium sulfate,alumosilicate, calcium carbonate, fumed silica, which could increase thehardness and rigidity of the immobilization cast.

[0066] Polymeric foam tapes can be utilized as substrates for thePlaster of Paris as well. Partially or slightly hydrophilic foam tapesubstrate, or even foam tape substrate containing Plaster of Paris as afiller, can be used in Plaster of Paris casts.

[0067] The curable resin can be applied to one side of the polymericfoam tape substrate, both sides of the substrate, and/or it can beapplied to the interior of the foam.

[0068] The immobilization tapes and casting articles of the presentinvention can be made of various lengths, thicknesses, and widths.

[0069] The immobilization tapes and casting articles of the presentinvention can be packaged in a way to minimize exposure to moisture,that includes dry packaging, vacuum packaging, and any proceduresutilized in packaging of water curable synthetic casts and various othercasting articles that include splints.

[0070] The following non-limiting examples, demonstrate immobilizationtapes that utilize reticulated polyurethane foam tapes as substrates andisocyanate prepolymers as water curable resins.

EXAMPLES Example 1

[0071] Reticulated polyether polyurethane foam of black color (Z/SIF,Product No. PDQZ45MA, FOAMEX International, Inc.) with about 45 poresper inch, density of about 2 pcf, extendibility of up to about 200%, anddimensions of about 12.0 inches by about 15.0 inches by about 2.25inches. The foam was machine sliced into tape substrates with thefollowing dimensions: about 12.0 inches by about 2.25 inches andthickness of about 1.0 mm (about 170 cm²). The weight of this tapesubstrate was about 1.0 g.

Example 2

[0072] Reticulated polyether foam of beige color (Z/SIFI, Product No.EFLTZ88A, FOAMEX International, Inc.) with about 88 pores per inch,about 1.9 pcf density, extensibility of up to 200%, and dimensions ofabout 15.0 inches by about 10.0 inches by about 2.0 inches. It wassliced by machine cutting into tape substrates with the followingdimensions: about 10.0 inches by about 2.0 inches and thickness of about1.0 mm. The weight of this tape substrate was about 0.6 g.

Example 3

[0073] About 12.0 inches long and about 3.0 inches wide polyestersubstrate (about 228 cm²), which are used in commercial synthetic casts,weighs about 4.9 g. The tape substrate of type from Example 1(reticulated foam), with the approximately same area (about 228 cm²) andnearly the same thickness (about 1 mm) as polyester substrate weighsignificantly less, about 1.3 g.

Example 4

[0074] Commercially available (about 12 inches by about 3 inches)synthetic immobilization tape (Johnson & Johnson, Flash Cast Elite) withpolyester substrate and NCO-prepolymer was dipped in water for about 5seconds. The weight of the substrate was about 4.9 g and the weight ofthe water curable resin on the substrate about 5 g, for the total tapeweight of about 9.9 g. The tape was applied, while slightly stretching,around a glass tube with the external diameter of about 25 mm that iscoated with aluminum foil. The temperature of the tape increased duringcuring and it hardened (set) in about 5-6 minutes.

Example 5

[0075] NCO-prepolymer (of about 12% NCO content) was prepared byreacting polymeric isocyanate and short-chain diol. Tertiary aminecatalyst (to promote curing with water) and defoaming agent were addedto the resin. About 5.0 g of this resin were coated on the surface ofthe reticulated foam tape substrate, of type from Example 1 (about 12.0inches by 2.25 inches by 1 mm), that by itself weighs about 1.1 g. Thetape was dipped in water for about 5 seconds and then, while slightlystretching, was applied (wound) around a glass tube with the externaldiameter of about 25 mm that was coated with aluminum foil. Thetemperature of the tape increased slightly and hardened (set) in about 5minutes.

Example 6

[0076] NCO-prepolymer (of about 12% NCO content) was prepared byreacting polymeric isocyanate and short-chain diol. Tertiary aminecatalyst (to promote curing with water) and defoaming agent were addedto the resin. About 7.5 g of the resin was coated to the reticulatedfoam tape substrate, of type from Example 1 (about 12.0 inches by about2.25 inches by about 1 mm), that by itself weighs about 1.0 g. The tapewas dipped in water for about 5 seconds and then was wound, whileslightly stretching, around a glass tube with the external diameter ofabout 25 mm that was coated with aluminum foil. The tape hardened inabout 5 minutes, and was harder than the cast in Example 5. Therefore,an increase in the amount of isocyanate resin in the casting tape canincrease the hardness of the cured tape. Furthermore, addition ofvarious fillers to foam tape substrates and changes in isocyanates watercurable agent formulation can affect the physical properties of thecured tape.

Example 7

[0077] About 7.0 g of NCO-prepolymer (of 12% NCO content) resincontaining tertiary amine catalyst and defoaming agent was coated ontoreticulated foam tape substrate, of type from Example 1 (about 12.0inches by about 2.25 inches by about 1 mm), which weigh about 0.7 g. Thetape was transferred into a vacuum oven at room temperature in themoisture-free environment and kept for one hour to allow the resin topenetrate into the foam tape substrate. Afterwards, the tape was dippedin water for about 5 seconds and then was wound, while slightlystretching, around a glass tube with the external diameter of about 25.0mm that was coated with aluminum foil. In this case, the tape beforecuring appeared less tacky than observed in previous Examples 4-6.Therefore, a method in which the curable resin is applied onto the tapesubstrate can affect the properties of the tapes before and after it hasbeen cured. In certain embodiments related to manufacturing, thepresence of water is minimized during the tape preparation.

Example 8

[0078] Polyurethane reticulated foam tape substrate, of type fromExample 2, was coated with about 7.0 grams of NCO-prepolymer (of about12% NCO content) resin containing tertiary amine catalyst and defoamingagent. The tape was dipped in water for about 5 seconds and then waswound, while slightly stretching, around a glass tube with the externaldiameter of about 25.0 mm that was coated with aluminum foil. This tapewas significantly less tacky than observed in Examples 5-7. The tapehardened in about 3 minutes. Therefore, the absorption of curing agentinto polymeric foam tape substrate can depend on the cell size and celldensity of the foam tape substrate. In addition, the chemical make up ofthe foam tape substrate and curable resin can affect their compatibilityand therefore absorption of the curable resin into the foam tapesubstrate. As a result properties of the tape before and after curingcould be affected.

Example 9

[0079] Three casting samples (A, B, and C) were prepared similar to thatin Example 8 utilizing the foam tape substrate from the foam of typefrom Example 2. In all cases the tackiness was lower than in Examples4-7; the tapes were applied with standard gloves or even bare hands. Itappears that most of the reactive resin was absorbed inside the tapesubstrate.

[0080] The compressive strength of the cured casts A, B, and C wasmeasured by using an Instron Universal Tester. The compressive strengthis given in Table 1. TABLE 1 Compression properties of the casts Cast# AB C Tape substrate weight (g) 0.60 0.72 0.55 Prepolymer weight (g) 5.05.0 5.0 Total weight (g) 4.94 5.47 5.13 Inner/outer diameter of thecylindrical 25/29.5 25/29.7 25/29.7 cast (mm) Compression load at 2%strain (lbs) 6.1 4.8 5.8 Compression load at 5% strain (lbs) 13.1 10.813.0 Compression load at 10% strain (lbs) 20.7 17.9 20.6 Compressionload at 20% strain (lbs) 27.2 27.6 28.1

[0081] While embodiments of the invention have been illustrated anddescribed, it is not intended that these embodiments illustrate anddescribe all possible forms of the invention. Rather, the words used inthe specification are words of description rather than limitation, andit is understood that various changes may be made without departing fromthe spirit and scope of the invention.

What is claimed is:
 1. An orthopedic casting article comprising apolymeric foam tape containing one or more curable resins.
 2. Theorthopedic casting article of claim 1, wherein the polymeric foam tapehas a thickness of about {fraction (1/128)} inch (about 0.2 mm) to about{fraction (3/16)} inch (about 5 mm) and a width of about ½ inch to about24 inches.
 3. The orthopedic casting article of claim 1, wherein thepolymeric foam tape is a continuous tape with a length of at least about6 inches.
 4. The orthopedic casting article of claim 1, wherein thepolymeric foam tape is comprised of a thermoset or thermoplasticpolymeric foam.
 5. The orthopedic casting article of claim 1, whereinthe polymeric foam tape is comprised of a foam having a substantiallyopen cell structure.
 6. The orthopedic casting article of claim 1,wherein the polymeric foam tape is comprised of a foam having asubstantially closed cell structure.
 7. The orthopedic casting articleof claim 1, wherein the polymeric foam tape is comprised of a foamhaving a substantially reticulated cell structure.
 8. The orthopediccasting article of claim 1, wherein the polymeric foam tape is comprisedof a foam having an average cell density greater than about 10 pores perinch (ppi).
 9. The orthopedic casting article of claim 1, wherein thepolymeric foam tape is comprised of a foam having an elasticity greaterthan about 1%.
 10. The orthopedic casting article of claim 1, whereinthe polymeric foam tape is comprised of a foam being flexible,semi-rigid, semi-flexible, viscoelastic, resilient or rigid.
 11. Theorthopedic casting article of claim 1, wherein the polymeric foam tapeis comprised of a foam having an affinity to water in the range ofhydrophilic to hydrophobic.
 12. The orthopedic casting article of claim1, wherein the polymeric foam tape is comprised of a foam having anaverage density of about 1.6 kg/m³ to about 960 kg/m³.
 13. Theorthopedic casting article of claim 1, wherein the polymeric foam tapeis comprised of a foam having a uniform or variable polymer compositionstructure.
 14. The orthopedic casting article of claim 1, wherein thepolymeric foam tape is comprised of a foam having at least one variableproperty throughout, wherein the variable property is selected from thegroup consisting of density, cell density, cell geometry, cell size,affinity to water, elasticity, thickness and width.
 15. The orthopediccasting article of claim 1, wherein the polymeric foam tape is comprisedof a foam based on one or more isocyanate or isocyanate containingcompounds, wherein the one or more isocyanates and isocyanate containingcompounds includes aliphatic isocyanate, aromatic isocyanate,cycloaliphatic isocyanate or a mixture thereof.
 16. The orthopediccasting article of claim 1, wherein the polymeric foam tape is comprisedof a polyurethane foam, being a product of a reaction of one or morepolyols with one or more isocyanates or isocyanate containing compounds.17. The orthopedic casting article of claim 1, wherein the polymericfoam tape is comprised of a polyurea foam, being a product of a reactionof one or more polyamines with one or more isocyanates or isocyanatecontaining compounds.
 18. The orthopedic casting article of claim 1,wherein the polymeric foam tape is selected from the group consisting ofpolyolefin-based polymers, polyester-based polymers, polyether-basedpolymers, polystyrene-based polymers and mixtures thereof.
 19. Theorthopedic casting article of claim 1, wherein the polymeric foam tapeincludes one or more additives to alter the surface properties of thepolymeric foam or adhesion to the one or more curable resins or to alterthe mechanical properties of the orthopedic casting materials.
 20. Theorthopedic casting article of claim 1, wherein one or more curableresins is applied on one side of the polymeric foam tape.
 21. Theorthopedic casting article of claim 1, wherein one or more curableresins is applied on one or more curable resins is applied on one orboth sides of the polymeric foam tape or into the interior of thepolymeric foam tape.
 22. The orthopedic casting article of claim 1,wherein the curable resin is applied to the polymeric foam tape at aload of about 99/1 resin to polymeric foam tape weight ratio to 1/99resin to polymeric foam tape weight ratio.
 23. The orthopedic castingarticle of claim 1, wherein at least one of the one or more curableresins is comprised of a water-curable resin.
 24. The orthopedic castingarticle of claim 23, wherein at least one of the one or more watercurable resins is comprised of an isocyanate containing material. 25.The orthopedic casting article of claim 24, wherein the isocyanatecontaining material is selected from the group consisting or aromaticisocyanates, aliphatic isocyanates, cycloaliphatic isocyanates,isocyanate-based adducts, isocyanate-based derivatives,isocyanate-prepolymers, isocyanate-oligomers, isocyanate-quasiprepolymers, and mixtures thereof.
 26. The orthopedic casting article ofclaim 24, wherein the isocyanate containing material has an isocyanateto active hydrogen equivalent weight ratio greater than about
 1. 27. Theorthopedic casting article of claim 24, wherein the isocyanatecontaining material contains at least one catalyst promoting thereaction of the isocyanate with water.
 28. The orthopedic castingarticle of claim 23, wherein at least one of the one or more watercurable resins is comprised of Plaster of Paris.
 29. The orthopediccasting article of claim 1, wherein at least one of the one or morecurable resins is cured via chemical reaction, UV light, laser light,radiation, or heat induced reaction.
 30. An orthopedic casting splintcomprising two or more layers, wherein one or more of the layers iscomprised of a polymeric foam tape containing one or more curableresins.
 31. The orthopedic casting splint of claim 30, wherein thepolymeric foam tape is comprised of a thermoset or thermoplasticpolymeric foam.
 32. The orthopedic casting splint of claim 30, whereinthe polymeric foam tape is comprised of a foam having a substantiallyopen cell structure, a substantially closed cell structure, or asubstantially reticulated cell structure.
 33. The orthopedic castingsplint of claim 30, wherein one or more of the layers is comprised of awoven, non-woven, knitted, or extruded layer.
 34. The orthopedic castingsplint of claim 30, wherein the splint is made in a shape of a sleeve.35. The orthopedic casting splint of claim 30, wherein the splint ismade in a shape of a glove or sock.
 36. A method for applying anorthopedic casting article to a body member, the method comprising:winding a polymeric foam tape containing one or more curable resinsaround a body member; and curing the one or more curable resins before,during, or after the polymeric foam tape is wound around the bodymember.
 37. The method of claim 36, further comprising cutting orslicing the polymeric foam tape to a length capable of partially orfully immobilizing the body member.
 38. A method for applying anorthopedic casting splint to a body member, the method comprising:providing a splint comprising two or more layers, wherein one or more ofthe layers is comprised of a polymeric foam tape containing one or morecurable resins; fully or partially enveloping the splint around a bodymember; and curing the one or more curable resins before, during, orafter the polymeric foam tape is enveloped around the body member. 39.The method of claim 38, further comprising cutting or slicing the splintto a shape capable of partially or fully immobilizing the body member.40. The method of claim 38, wherein the enveloping step includesinserting the body member into the splint.